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Oncobiologics, Inc. presented final data from the Phase I trial evaluating bioequivalence of ONS-3010 (Humira biosimilar) and the US and European originator versions of Humira (adalimumab).

The data was presented at the 2016 American College of Rheumatology Annual Scientific Meeting in Washington, DC on November 13, 2016.

The Phase I ONS-3010 trial demonstrated pharmacokinetic (PK) bioequivalence on the primary and secondary endpoints for the biosimilar candidate and the US and EU originator product (Humira). There was no significant difference in immunogenicity or overall safety, except for a reduction in the burning sensation at the ONS-3010 injection site.

“This final Phase I data clearly suggests that ONS-3010 is highly biosimilar to the originator adalimumab products,” said Kenneth Bahrt, M.D., FACR, Chief Medical Officer of Oncobiologics. “Of note, is the reduced burning sensation at the injection site, which can be an important differentiator for our biosimilar candidate,” he concluded.

Three randomized, gender-balanced groups of 66 healthy subjects received single subcutaneous doses of 40mg of either ONS-3010 or Humira (EU or US product). Blood samples were collected at regular intervals for PK and immunogenicity testing. Bioequivalence was assessed using general linear model procedures. Adverse events and serious adverse events were monitored and recorded.

Top line results included:

The PK profiles for E.U. Humira, U.S. Humira and ONS-3010 were similar in outcome.

For AUC0-inf and Cmax, the primary endpoints, bioequivalence was demonstrated .

Bioequivalence was also demonstrated for the secondary PK endpoint, AUC0-last.

Adverse events were evenly divided over treatments, usually mild in severity, and self-limiting.

A single serious adverse event (bacterial abscess) occurred in the ONS-3010 arm.

Immunogenicity results showed similar profiles in the three treatment groups for anti-drug and neutralizing antibodies.

Oncobiologics Chairman and Chief Executive Officer Pankaj Mohan, Ph.D., added, “We are pleased with the data on ONS-3010, especially the finding of reduced injection site discomfort using our proprietary formulation. As we prepare for our Phase 3 clinical study, we believe that ONS-3010 can become a new affordable option for patients suffering from rheumatoid arthritis. Ultimately, our goal is to offer a biosimilar product that provides both economic and therapeutic benefits to payors, buying groups, physicians and, most importantly, patients.”

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